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Comparison of In-House Methods and Cobas BRAF V600 Mutation Assay in Melanoma Tumor Samples

25. februar 2016 opdateret af: Hoffmann-La Roche

Evaluation of Concordance Between the Methods Used in INCa Platforms and the Cobas® 4800 BRAF V600 Mutation Test for Detection of BRAF V600 Mutations in Melanoma in Real Life Setting

This non-interventional study will compare the Cobas BRAF V600 mutation assay with in-house methods used in molecular laboratories for the assessment of the BRAF mutation status in melanoma tumor samples. No patients will be enrolled in this study. Data will be collected for approximately 6 months.

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

420

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Frankrig
      • Boulogne Billancourt, Frankrig, 92104
      • Colmar, Frankrig, 68024
      • Lille, Frankrig, 59037
      • Lyon, Frankrig, 69437
      • Marseille, Frankrig, 13015
      • Montpellier, Frankrig, 34295
      • Nantes, Frankrig, 44093
      • Paris, Frankrig, 75010
      • Pessac, Frankrig, 33604
      • Rouen, Frankrig, 76031
      • Vandoeuvre Les Nancy, Frankrig, 54511
      • Villejuif, Frankrig, 94505

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

No patients are enrolled in this study. Use of melanoma tumor samples.

Beskrivelse

Inclusion Criteria:

No patients are enrolled. Use of tumor samples only.

  • Histologically proven melanoma tumor sample
  • Any type of tumor sample: biopsy or surgical specimen of primary tumor or metastasis
  • Tumor samples must be fixed and paraffin-embedded.

Exclusion Criteria:

No patients are enrolled. Use of tumor samples only.

  • Fixative unknown

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
INCa molecular genetics laboratory "in-house" methods
BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using "in-house" methods
Cobas 4800 Mutation Test
BRAF V600 mutations were analysed using Cobas 4800 mutation test

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
BRAF Mutation Status According to Cobas 4800 BRAF V600 Mutation Test vs. INCa Laboratories Molecular Genetics Laboratories
Tidsramme: Up to 6 months
BRAF V600 mutation status was determined by INCa molecular laboratories "in-house" methods and Cobas 4800 BRAF V600 mutation test. Samples were analysed as V600 mutation, No V600 mutation and Non evaluable. Additionally, the type of V600 mutation (E, K, R, D, E2, other V600 mutation, not specified) was also evaluated only by INCa molecular laboratory "in-house" method.
Up to 6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Tumor Sample Characteristics-Type of Tumor Sample
Tidsramme: Up to 6 months
The type of tumor sample used for evaluation of BRAF V600 mutation whether it was a biopsy or surgical specimen were reported
Up to 6 months
Tumor Sample Characteristics - Source of Tumor Sample
Tidsramme: Up to 6 months
The source of tumor sample for BRAF V600 mutation detection whether taken from internal or external pathology laboratory were reported
Up to 6 months
Type of Pathology Laboratory Performing the Fixation or Embedding-Pre-analytical Method
Tidsramme: Up to 6 months
The external or internal pathology laboratories involved in the process of fixation or embedding of the tumor sample was evaluated.
Up to 6 months
Time From Sampling to Fixation- Pre-analytical Method
Tidsramme: Up to 6 months
Time taken from the sampling to the fixation of the tumor sample was reported in range of 0-2 hours, 2-6 hours, >6 hours and unknown. Number of samples falling in each of the class were reported.
Up to 6 months
Type of Fixative Used- Pre-analytical Method
Tidsramme: Up to 6 months
The different types of fixative Excell, formol, alcohol formol acetic acid and other, used to fix the tumor samples were reported.
Up to 6 months
Fixation Duration by Pre-analytical Method
Tidsramme: Up to 6 months
Fixation duration is defined as the amount of time required in hours for the fixation of a samples. The fixation duration was categorized as <6 hours, 6-24 hours and >24 hours and unknown. Number of samples falling in each category were reported
Up to 6 months
Slice Thickness by Pre-analytical Method
Tidsramme: Up to 6 months
Slice thickness of all the tumour samples was measured. The slice thickness was measured in micrometer.
Up to 6 months
Dewaxing by Pre-analytical Method
Tidsramme: Up to 6 Months
Dewaxing is a method to recover the DNA from samples. Dewaxing information was collected as "Yes, No or Missing"
Up to 6 Months
Necrosis Percentage Determination by Pre-analytical Method
Tidsramme: Up to 6 months
The percentage of necrosis defined as the death of one or more cells in the analysed zone was reported.
Up to 6 months
Percentage of Tumor Cells by Pre-analytical Method
Tidsramme: Up to 6 months
The percentage of tumor cells in the given tumor sample were reported.
Up to 6 months
Tumor Samples With Presence of Melanin by Pre-analytical Method
Tidsramme: Up to 6 months
The tumor samples with presence of melanin were categorized as Important, Few, Medium and Absent.
Up to 6 months
DNA Extraction - Extraction Method by Pre-analytical Method
Tidsramme: Up to 6 months
This method assessed DNA from the tumor samples was extracted by Automated method or Manual method.
Up to 6 months
Median DNA Elution Volume by Pre-analytical Method
Tidsramme: Up to 6 months
Median DNA elution volume microliters [mcl] was reported.
Up to 6 months
Mean DNA Concentration by Pre-analytical Method
Tidsramme: Up to 6 months
The DNA concentration in the tissue elute was measured in nanogram per microliter (ng/mcL).
Up to 6 months
Amount of DNA by Pre-analytical Method
Tidsramme: Up to 6 months
The total DNA concentration extracted from the tissue was measured in nanogram (ng).
Up to 6 months
Size of Amplicons Used by "In-house" Analytical Method
Tidsramme: Up to 6 months
The method described the size of amplicon used. It was measured in base pairs (bp).
Up to 6 months
Method of Mutation Detection by "In-house" Analytical Method
Tidsramme: Up to 6 months
Allele-specific PCR, High Resolution Melting (HRM) + Sanger sequencing, Pyrosequencing, Sanger sequencing, Real time PCR, SNaPshot were used for BRAF V600 mutation detection.
Up to 6 months
Number of Samples Punched in In-house Analytical Method
Tidsramme: Up to 6 months
Total number of samples for whom punch was used in 'in-house analytical' method are reported.
Up to 6 months
Mean Number of Slices Per Sample Used for "In-house"- Analytical Method
Tidsramme: Up to 6 months
The mean of number of slices per sample when no punch was used are reported.
Up to 6 months
Median Time Between Receipt of Samples and Determination of Result by "In-house" Analytical Method
Tidsramme: Up to 6 months
This In-house analytical method measured the time between receipt of samples to the result determination. It measured the time in days.
Up to 6 months
Technician Work Time Between DNA Extraction and Result by "In-house" Analytical Method
Tidsramme: Up to 6 months
The working time required by the technician from the time of DNA extraction to the time to obtain the results was measured in hours.
Up to 6 months
Mean DNA Concentration as Measured by COBAS 4800 BRAF V600 Mutation Test-Analytical Method
Tidsramme: Up to 6 months
The DNA concentration as assessed by COBAS 4800 BRAF V600 Mutation assay was reported. The unit used to measure the DNA concentration was nanogram/microlitre (ng/mcl)
Up to 6 months
Punch Used for Cobas 4800 BRAF V600 Mutation Test- Analytical Method
Tidsramme: Up to 6 months
The punch done during Cobas 4800 BRAF V600 Mutation Test on the sample was described as Yes or No.
Up to 6 months
Number of Slices Used When No Punch Was Used for Cobas 4800 BRAF V600 Mutation Test- Analytical Method
Tidsramme: Up to 6 months
This describes the Cobas 4800 BRAF V600 Mutation Test, for the mean of number of slices when No punch method, was used. Of the 420 samples, punch was Yes, for 45 samples and punch was No, for 375 samples.
Up to 6 months
Median Time Between Receipt of Sample and Determination of Result by Cobas 4800 BRAF V600 Mutation Test -Analytical Method
Tidsramme: Up to 6 months
This analytical method for cobas 4800 BRAF V600 Mutation Test measured the time between receipt of samples to the result determination. It measured the time in days.
Up to 6 months
Technician Work Time Between DNA Extraction and Result by Cobas 4800 BRAF V600 Mutation Test - Analytical Method
Tidsramme: Up to 6 months
This cobas 4800 BRAF V600 Mutation Test analytical method measures the working time required by the technician from the time of DNA extraction to the time to obtain the results. The time duration was measured in hours.
Up to 6 months
Management of Discordance- Method Used to Manage Discordance
Tidsramme: Up to 6 months
Crossing DNA, DNA from In-House method analysed with cobas, SNaPshot, DNA from cobas analysed with In-House method, external site control test, Sanger sequencing, Kit CE-IVD Therascreen RGQ Qiagen, Kit Therascreen RGQ BRAF + Pyrosequencing by another platform (PF), Pyrosequencing, Mutation detection On Another Block, (primitive tumor [prm. tmr]), Sequencing And Therascreen kit (Qiagen) were used for management of discordance between "in-house" method and Cobas 4800 mutation test.
Up to 6 months
Management of Discordance-Final Result for BRAF V600 Mutation Detection
Tidsramme: Up to 6 months
The final results obtained by discordance management of the 28 discordant samples were BRAF V600 mutation, No BRAF V600 mutation and Non-evaluable. These results were further assessed by the Investigator and interpreted as final result.
Up to 6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hoffmann-La Roche

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2012

Primær færdiggørelse (Faktiske)

1. april 2013

Studieafslutning (Faktiske)

1. april 2013

Datoer for studieregistrering

Først indsendt

6. december 2012

Først indsendt, der opfyldte QC-kriterier

6. december 2012

Først opslået (Skøn)

7. december 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

28. marts 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. februar 2016

Sidst verificeret

1. november 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ML28471

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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